A Phase 2 interventional study of Eculizumab and Normal Saline in Delayed Graft Function, Kidney Transplantation and Complement Activity, sponsored by Heeger, Peter, M.D.. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.
Sponsored by Heeger, Peter, M.D. · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of Delayed Graft Function following deceased donor kidney transplantation. Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent IR injury in high risk recipients. This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation and once again 24 hours later in preventing delayed graft function in first adult recipients of deceased donor kidneys.
Recipients of kidneys defined as:
Exclusion Criteria:
Eculizumab 1200 mg (diluted in Sodium Chloride (NaCl) to 5mg/mL, volume = 240 mL) will be given intraoperatively at the time of transplantation prior to reperfusion of the renal allograft and again at 900 mg (diluted in NaCl to 5mg/mL, volume = 180 mL) 12-24 hours post-transplantation
Drug: Eculizumab
Administered at same volume and time as Experimental arm
Drug: Normal Saline
Also known as: Soliris
Hemodialysis
The need of at least one dialysis treatment during the first 7 days after transplantation excluding: (i) requirement for a single dialysis session indicated for hyperkalemia (ii) hyperacute rejection, renal arterial and/or venous thrombosis, obstructive uropathy, recurrence of primary disease, and early thrombotic microangiopathy
Time frame: 7 days post-transplantation
Estimated Glomerular Filtration Rate (GFR)
Estimated GFR as determined from the 4-variable MDRD (Modified Diet in Renal Disease) equation on days 7, 30, 90 and 180 post-transplantation
Time frame: 6 months post-transplantation
Hemodialysis
Number of dialysis sessions at 30 days and 8 weeks post-transplantation
Time frame: 8 weeks post-transplantation
Primary Non-function
The incidence of primary non-function (PNF) defined as the need for dialysis-dependency for more than 8 weeks
Time frame: 8 weeks post-transplantation
Graft Rejection
Incidence of graft rejection within 6 months
Time frame: 6 months post-transplantation
Patient Survival
Patient survival at 12 months post-transplantation
Time frame: 12 months post-transplantation
Graft Survival
Death censored graft survival at 12 months post-transplantation
Time frame: 12 months post-transplantation
Serum Creatinine
Change from baseline in serum creatinine and serum creatinine concentration at 24, 48 and 72 hours post-transplantation
Time frame: 3 days post-transplantation
Urine Output
Percentage of patients with total 24-hour urine output of more than 500 mL on post-transplantation days 2 and 3
Time frame: 3 days post-transplantation
Biomarkers
Absolute levels of biomarkers associated with acute renal injury
Time frame: 6 months post-transplantation
Qualified Delayed Graft Function (qDGF)
The incidence of qDGF defined as the requirement for dialysis for any reason in the first 7 days post-transplantation
Time frame: 7 days post-transplantation
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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